Trial document




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  DRKS00014842

Trial Description

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Title

A transtheoretic approach to developing therapist interpersonal competencies and preventing negative outcome in depression treatment. A multi-center, randomized trial

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Trial Acronym

RCT Alliiance-Focused Training

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Tensions and ruptures in the therapeutic relationship are frequent. Successful management of those moments is both a prerequisite for successful psychotherapy and a central mechanism of change. However, therapists often find it difficult to detect ruptures in a timely manner and to handle it constructively. This indicates the need for specific training methods. The Alliance-Focused Training (Safran & Muran, 2000, Eubanks-Carter, Muran & Safran, 2015) is a promising approach to improve therapeutic skills in dealing constructively with ruptures in the therapeutic relationship. The study investigates whether therapists receiving the Alliance-Focused Training will be achieve better results in their treatments of patients with depression than therapists receiving training as usual.

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Brief Summary in Scientific Language

Alliance ruptures, (i.e. periods of tension or breakdown of the relationship between patient and therapist) inevitably occur in the course of any psychotherapy. They constitute a high risk of premature treatment termination and poor therapy outcome. Therapists often fail to notice alliance ruptures or lack the skills to deal with them constructively. Premature termination is particularly frequent in depression treatments - up to 1/3 of these patients drop out of psychotherapy.
Despite the importance of alliance ruptures in every practice and the serious implications resulting from therapists` inadequate / ineffective addressing / handling them, the curricula of psychotherapy training do not systematically address this topic so far.
The alliance-focused training (AFT, Eubanks-Carter, Muran & Safran, 2015) is a promising approach to enhance therapists’ skills in dealing with alliance ruptures independent of psychotherapeutic orientation using video recordings of therapy sessions and role plays as central elements. Previous research including an own pilot study (funded by the Heigl Foundation) emphasize the potential of the approach. However, evidence from RCTs is missing.
The proposed project intends to investigate the effectiveness of AFT (vs. psychotherapy training as usual, TAU) for trainee therapists treating depressed patients with Cognitive-behavioral therapy (CBT) or Psychodynamic psychotherapy (PDT). It is a prospective, parallel group, cluster-randomized controlled multicentre trial, stratified by cooperation centre and treatment approach (CBT vs. PDT), with an active control group. Trainee therapists (CBT or PDT) will be? randomized to either AFT or TAU. Patients will be clustered within trainee therapists and assigned to trainees receiving AFT vs. TAU. Co-primary hypotheses are: 1. Patient dropout after 24 sessions is lower in AFT compared to TAU (superiority). 2. Reduction of depressive symptoms after 24 sessions is comparable in AFT compared to TAU (non-inferiority with a non-inferiority margin of 8.46 BDI-II units). Furthermore, we expect a stronger reduction of anxiety, somatic complaints, personality structure problems, interpersonal problems, and a stronger increase in quality of life in AFT compared to TAU. In addition, we hypothesize that better outcomes with AFT training are mediated by the quality of the therapeutic alliance and by psychotherapy trainees’ interpersonal competence. Outcome data will be collected at baseline, and after session 8, 16, and 24 (post). Treatment duration is initially planned for 24 sessions, but can be prolonged for up to 60 sessions?.
The study has the potential to contribute to improving psychotherapy training and psychotherapy outcome for depression.

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Organizational Data

  •   DRKS00014842
  •   2018/07/10
  •   [---]*
  •   yes
  •   Approved
  •   [---]*, Ethikkommission der Psychologischen Hochschule Berlin
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Secondary IDs

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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F34.1 -  Dysthymia
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Interventions/Observational Groups

  •   Alliance Focused Training (AFT) consisting of an initial workshop followed by group supervision with usual frequency and dose but AFT-specific concept (aims at enhancing therapists’ interpersonal skills in dealing successfully with ruptures in the therapeutic alliance).
  •   Psychotherapy Training as usual (TAU), regularly supervised with frequency and dose as usual.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Patient dropout (patient/therapist interview), depressive symptoms (BDI-II)

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Secondary Outcome

Anxiety (GAD-7),
Somatic symptoms (PHQ-15),
Personality structure (IPO-16),
Interpersonal problems (IIP-64-R),
Quality of life (WHOQOL)
Pre-Post Differences in each case

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
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Recruitment

  •   Planned
  •   2020/10/01
  •   240
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Outpatients, Cognitive-behavioral (CBT) or Psychodynamic (PDT) therapy, once-weekly 50min sessions; both sexes; ≥ 18 yrs.; primary DSM-IV diagnosis of unipolar affective disorder; BDI-II score ≥ 14.29; informed consent.

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Exclusion Criteria

Current/past diagnosis of psychotic disorder or dementia; substance dependency disorder (current/during the last 12 months); acute suicidal plans or attempts within the last 6 months; concurrent psychotherapy; pharmacotherapy other than antidepressants or change of antidepressant regimen during the last month; insufficient command of the German language;

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Addresses

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    • Professur für Psychosomatik und Psychotherapie, Psychologische Hochschule Berlin
    • Ms.  Prof.  Antje  Gumz 
    • Am Köllnischen Park 2
    • 10179  Berlin
    • Germany
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    • Professur für Psychosomatik und Psychotherapie, Psychologische Hochschule Berlin
    • Ms.  Prof.  Antje  Gumz 
    • Am Köllnischen Park 2
    • 10179  Berlin
    • Germany
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    • Psychologische Hochschule Berlin
    • Ms.  Prof.  Antje  Gumz 
    • Am Köllnischen Park 2
    • 10179  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Psychologische Hochschule Berlin
    • Ms.  Prof.  Antje  Gumz 
    • 10179   Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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